FDA Drug recall D-857-2013
Acetylcysteine Ophthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA
- FDA Drug
- Class II
- terminated
- Published 2013-08-21
On 2013-08-21 the FDA classified a Class II recall of Acetylcysteine Ophthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA by Pallimed Solutions, citing lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-857-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-25 |
| Published | 2013-08-21 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pallimed Solutions |
| Distribution | US |
Product
Acetylcysteine Ophthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Identifiers
| code_info | All lots within expiry |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-857-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.